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Terminated

EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.

FDA Recall Z-1607-2008 · Posted 2008-09-16

Recalling FirmEMD Chemicals Inc
Recall StatusTerminated
Product CodeDNN
Date Initiated2008-03-27
Date Terminated2008-09-22
Product Quantity99 cases (10 ampules per case)

Reason for Recall

Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.

Firm Action

VWR International and Thermo Fisher Scientific were notified of the recall by e-mail on 3/27/08 and asked to provide end user lists so that recall letters could be sent to each customer. Customers were sent a letter commencing April 3, 2008, by first class mail.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc. · 1999-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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